Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05609578 | Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation | PHASE2 | RECRUITING | 90 | — | — | Nov 22, 2022 | Dec 1, 2026 | Aug 17, 2025 | 166 | United States, Brazil +12 |
Defined as the percent of patients documented to have a confirmed CR or PR
PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Cohort A: PD-L1 TPS≥ 1% (Closed) | EXPERIMENTAL | Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles |
| Cohort C | EXPERIMENTAL | Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles |
| Cohort E | EXPERIMENTAL | Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles) |
| Name | Type | Description |
|---|---|---|
| Adagrasib oral dose of 400 mg twice daily tablets | DRUG | oral dose of 400 mg twice daily tablets |
| Pembrolizumab | COMBINATION_PRODUCT | IV infusion once every 3 weeks |
| Chemotherapy: Pemetrexed | COMBINATION_PRODUCT | IV infusion once every 3 weeks |
| Cisplatin/Carboplatin | COMBINATION_PRODUCT | IV infusion once every 3 weeks |
Cohort A\* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%. * Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squam...